Company ยท US
Smith & Nephew, Inc. Endoscopy Division
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2013. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
121recalls (0 in 12 months)
89recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 31 |
| NBH | Accessories, Arthroscopic | 18 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 13 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 12 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 11 |
| JDR | Staple, Fixation, Bone | 11 |
| HRX | Arthroscope | 6 |
| MQV | Filler, Bone Void, Calcium Compound | 4 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 3 |
| GXI | Probe, Radiofrequency Lesion | 3 |
| NBW | System, Test, Blood Glucose, Over The Counter | 3 |
| FWF | Camera, Television, Endoscopic, Without Audio | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 |
| HAB | Saw, Powered, And Accessories | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 |
| DWQ | Stripper, Vein, External | 1 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 |
| JEB | Table, Surgical With Orthopedic Accessories, Manual | 1 |
| KGS | Retention Device, Suture | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 2013 | K121904 | GYNECOLOGY STERILIZATION TRAY Smith & Nephew Inc., Endoscopy Division | KCT |
| Jan 5, 2011 | K102982 | ENDOBUTTON DIRECT Smith & Nephew Inc., Endoscopy Division | MAI |
| Nov 3, 2008 | K082215 | OSTEORAPTOR SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Division | JDR |
| Jul 16, 2008 | K081098 | ENDOBUTTON CONTINUOUS LOOP (CL) Smith & Nephew Inc., Endoscopy Division | JDR |
| Dec 10, 2007 | K072785 | TWINFIX FT PK Smith & Nephew Inc., Endoscopy Division | HWC |
| Aug 17, 2007 | K071586 | BIORAPTOR 2.3 PK SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Division | MBI |
| May 16, 2007 | K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Division | MBI |
| Apr 12, 2007 | K070167 | ENDOBUTTON DIRECT Smith & Nephew Inc., Endoscopy Division | MBI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra S Double Loaded Suture
Product Code: 72203854
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white)
Product Code: 72203853
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue)
Product Code: 72203852
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture
Product Code: 72203842
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue
Product Code: 72203841
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597
Biodegradable suture anchor Terminated |
MAI | K093844 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290
Biodegradable suture anchor Terminated |
JDR | K082215 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291
Biodegradable suture anchor Terminated |
JDR | K082215 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165
Biodegradable suture anchor Terminated |
JDR | K082215 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996
Biodegradable suture anchor Terminated |
JDR | K082215 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994
Biodegradable suture anchor Terminated |
JDR | K082215 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992
Biodegradable suture anchor Terminated |
JDR | K082215 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991
Biodegradable suture anchor Terminated |
JDR | K082215 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995
Biodegradable suture anchor Terminated |
JDR | K082215 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993
Biodegradable suture anchor Terminated |
JDR | K082215 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile
Part Number: 72202897
Product Usage: intended for use for the
reattachment of soft tissue to bone Terminated |
MBI | K100159 |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile
Part Number: 72202896
Product Usage: intended for use for the
reattachment of soft tissue to b Terminated |
MBI | K100159 |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile
Part Number: 72202895
Product Usage: intended for use for the
reattachment of soft tissue to bone Terminated |
MBI | K100159 |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles
Product Usage: intended for use for the
reattachment of soft tissue to bone
Part Terminated |
MBI | K100159 |
| Aug 3, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade
Full Radius
Part Number: 7205962
Product Usage:
The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of l Terminated |
GEI | K012314 |
| Aug 3, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER
Part Number: 72202213
Product Usage:
The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical Terminated |
GEI | K012314 |
| May 1, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 560P High Definition Camera Control Unit
Catalog Number: 72201919
The 560P camera system is configured to be connected as a stand-alone system on an endoscopic cart or tower. It is desi Terminated |
GCJ | K070266 |
| Mar 19, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm
Catalog Number: 72201772.
The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anter Terminated |
HWC | K080358 |
| Jan 11, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger
Catalog Number: 72203299.
Table, Operating-room, Pneumatic. Terminated |
FQO | None listed |
| Jan 11, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector
Catalog Number: 7205962. Terminated |
GEI | K012314 |
| Oct 21, 2011 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, HD1200 Autoclavable Camera Head
Catalog Number: 72203360
Product Usage: Endoscope & Accessories Terminated |
GCJ | K014158 |
| Aug 22, 2011 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x
12 working length. Non-Sterile
Catalog Number: 013554
Orthopedic Manual Surgical Instrument Terminated |
LXH | None listed |
| Jul 1, 2011 | Smith & Nephew, Inc. Endoscopy Division DYONICS POWER Shaver Blades,
4.5mm Long Full Radius, package of 3
Catalog Number: 7205341
Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and o Terminated |
HAB | None listed |
| Jul 1, 2011 | Smith & Nephew, Inc. Endoscopy Division DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3.
Catalog Number: 7205336
Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resectio Terminated |
HAB | None listed |
| Jun 24, 2011 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Hip Arthroscopy Repair Instrument Tray
Part Number: 72202732
Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable su Terminated |
KCT | K102544 |
| Nov 18, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE
Catalog Number; 72202469.
Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as sho Terminated |
GAT | K092508 |
| Nov 18, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew FAST FIX 360, CURVED NEEDLE
Catalog Number; 72202468.
Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder st Terminated |
GAT | K092508 |
| Nov 18, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE
Catalog Number; 72202467.
Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder Terminated |
GAT | K092508 |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 4mm Offset (Green)
Catalog Number: 72201716F (Refurbished)
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
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