Company ยท US
Surgical Specialties Corp
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2016. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 9 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 5 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 5 |
| EFQ | Gauze/Sponge, Internal | 4 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 3 |
| GAP | Suture, Nonabsorbable, Silk | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 2 |
| HNN | Knife, Ophthalmic | 2 |
| DTH | Suture, Cardiovascular | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| GAN | Suture, Absorbable, Synthetic | 1 |
| HNO | Keratome, Ac-Powered | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 |
| LZU | Plug, Punctum | 1 |
| MTJ | Wax, Bone | 1 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 2016 | K160744 | LOOK PTFE Suture Surgical Specialties Corporation, MX | NBY |
| Jul 30, 2014 | K141778 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corporation | GAM |
| Jul 18, 2014 | K141625 | POLYSYN SURGICAL SUTURE Surgical Specialties Corp | GAM |
| Jul 11, 2014 | K141558 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE Surgical Specialties Corp | GAM |
| Feb 28, 2014 | K140227 | MONODERM SURGICAL SUTURE Surgical Specialties Corp | GAM |
| Apr 23, 2008 | K080985 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) Surgical Specialties Corp | NEW |
| Mar 21, 2008 | K080680 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE Surgical Specialties Corp | NEW |
| Aug 6, 2007 | K071989 | QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL Surgical Specialties Corp | NEW |
| Aug 3, 2007 | K072028 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM Surgical Specialties Corp | GAM |
| May 9, 2007 | K063680 | SHARPOINT PDO (POLYDIOXANONE) SUTURES Surgical Specialties Corp | NEW |
| Jan 18, 2006 | K053380 | CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE Surgical Specialties Corp | NEW |
| Dec 6, 2005 | K052962 | OPTIMIZED BARB DESIGN Surgical Specialties Corp | GAW |
| Nov 7, 2005 | K052437 | MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE Surgical Specialties Corp | GAM |
| Apr 1, 2005 | K050548 | CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS Surgical Specialties Corp | GAW |
| Mar 9, 2005 | K050292 | SHARPOINT LUKENS BONE WAX Surgical Specialties Corp | MTJ |
| Mar 4, 2005 | K050247 | CONTOUR NECKLIFT THREADS Surgical Specialties Corp | GAW |
| Dec 3, 2004 | K042856 | CONTOUR FOREHEAD/BROWLIFT THREAD Surgical Specialties Corp | GAW |
| Sep 20, 2004 | K041593 | FEATHERLIFT EXTENDED LENGTH APTOS THREAD Surgical Specialties Corp | GAW |
| May 18, 2004 | K040477 | MONODERM Surgical Specialties Corp | GAM |
| Jul 26, 2002 | K020882 | SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG Surgical Specialties Corp | LZU |
| Jan 28, 2002 | K014021 | SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED Surgical Specialties Corp | GAM |
| Dec 15, 2000 | K003015 | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD Surgical Specialties Corp | GAN |
| Oct 18, 2000 | K002849 | PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES Surgical Specialties Corp | HNO |
| Sep 7, 2000 | K001765 | LOOK COLLAGEN SPACERS, MODEL 1514B Surgical Specialties Corp | KXK |
| Jan 7, 1994 | K932038 | SUTURE NONABSORBABLE- SILK, POLYESTER Surgical Specialties, Inc. | GAT |
| Jan 7, 1994 | K932037 | SUTURE ABSORBABLE- GUT Surgical Specialties, Inc. | GAR |
| Jan 7, 1994 | K930826 | SUTURE NONABSORBABLE - SILK Surgical Specialties, Inc. | GAP |
| Jan 7, 1994 | K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES Surgical Specialties, Inc. | GAP |
| Nov 23, 1987 | K874219 | S3 MEDICATED GAUZE Surgical Specialties, Inc. | FRO |
| May 6, 1986 | K861446 | S1 ORAL PACKING Surgical Specialties, Inc. | EFQ |
| May 6, 1986 | K861445 | S1 CAVITY PACKING Surgical Specialties, Inc. | EFQ |
| May 6, 1986 | K861444 | S1 NASAL PACKING Surgical Specialties, Inc. | EFQ |
| May 6, 1986 | K861443 | S1 VAGINAL PACKING Surgical Specialties, Inc. | EFQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2024 | SURGICAL SPECIALTIES POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N Open, Classified |
GAM | K965162 |
| May 4, 2011 | Surgical Specialties Corp SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle.
Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular Terminated |
DTH | K903029 |
| Oct 2, 2008 | Surgical Specialties Corp 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures. Terminated |
GAR | K930825 |
| Oct 21, 2005 | Surgical Specialties Corp Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units. Terminated |
GAR | None listed |
| Jul 20, 2004 | Surgical Specialties Corp Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed) Terminated |
GAT | None listed |
| Oct 15, 2003 | Surgical Specialties Corp Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. Terminated |
HNN | K822112 |
| Apr 1, 2003 | Surgical Specialties Corp Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm. Terminated |
HNN | K822112 |
| Feb 5, 2003 | Surgical Specialties Corp 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End Terminated |
GEA | None listed |
| Feb 5, 2003 | Surgical Specialties Corp 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End Terminated |
GEA | None listed |