Company ยท US
United States Surgical, A Division of Tyco Healthc
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2007. Name variants (Inc, Corp, punctuation) are merged.
218510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 30 |
| GDW | Staple, Implantable | 28 |
| FZP | Clip, Implantable | 17 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 12 |
| HET | Laparoscope, Gynecologic (And Accessories) | 9 |
| HAO | Instrument, Surgical, Non-Powered | 7 |
| FTL | Mesh, Surgical, Polymeric | 5 |
| GAP | Suture, Nonabsorbable, Silk | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 |
| HRX | Arthroscope | 5 |
| GAL | Suture, Absorbable, Natural | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 4 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 3 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 3 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 3 |
| GDH | Gouge, Surgical, General & Plastic Surgery | 3 |
| KNW | Instrument, Biopsy | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 |
| LRC | Instrument, Ent Manual Surgical | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2007 | K071406 | AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER United States Surgical, A Division of Tyco Healthc | FZP |
| Sep 28, 2007 | K071920 | AUTOSUTURE ABSORBABLE TACK AND APPLICATOR United States Surgical, A Division of Tyco Healthc | GDW |
| Nov 2, 2006 | K061288 | AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER United States Surgical, A Division of Tyco Healthc | FZP |
| Oct 23, 2006 | K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS United States Surgical, A Division of Tyco Healthc | GDW |
| Sep 1, 2006 | K062326 | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE United States Surgical, A Division of Tyco Healthc | GCJ |
| May 31, 2006 | K061095 | AUTO SUTUR ENDO GIA STAPLERS United States Surgical, A Division of Tyco Healthc | GDW |
| Jun 1, 2005 | K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE United States Surgical, A Division of Tyco Healthc | GAW |
| Sep 24, 2004 | K042412 | MODIFIED SPACEMAKER SYSTEM United States Surgical, A Division of Tyco Healthc | GCJ |
| Mar 31, 2004 | K040594 | HERCULON SOFT TISSUE REATTACHMENT SYSTEM United States Surgical, A Division of Tyco Healthc | HWC |
| Dec 1, 2003 | K032696 | AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT United States Surgical, A Division of Tyco Healthc | GDW |
| Nov 17, 2003 | K032586 | CAPROSYN ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Mar 14, 2003 | K024275 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER United States Surgical, A Division of Tyco Healthc | GDW |
| Nov 19, 2002 | K020804 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER United States Surgical, A Division of Tyco Healthc | GDW |
| Apr 15, 2002 | K020134 | SPIRAL RADIUS 90-D RODDING SYSTEM United States Surgical, A Division of Tyco Healthc | KWP |
| Jan 8, 2002 | K013671 | L-25 ABSORBABLE SURIGCAL SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Dec 19, 2001 | K013860 | AUTO SUTURE SURGICAL STAPLES United States Surgical, A Division of Tyco Healthc | GDW |
| Dec 11, 2001 | K013890 | SURGICAL DYNAMICS MENISCAL STAPLE United States Surgical, A Division of Tyco Healthc | HWC |
| Sep 6, 2001 | K012539 | VERASTEP United States Surgical, A Division of Tyco Healthc | GCJ |
| Aug 15, 2001 | K012273 | SPIRAL RADIUS 90-D SST SYSTEM United States Surgical, A Division of Tyco Healthc | MNH |
| Jul 18, 2001 | K003709 | SURGICAL DYNAMICS MESH CAGE SYSTEM United States Surgical, A Division of Tyco Healthc | MQP |
| Apr 4, 2001 | K010035 | IVS TUNNELLER United States Surgical, A Division of Tyco Healthc | FTL |
| Dec 8, 2000 | K001895 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER United States Surgical, A Division of Tyco Healthc | GDW |
| Aug 16, 2000 | K002008 | SURGICAL DYNAMICS SPINAL RETRACTOR United States Surgical, A Division of Tyco Healthc | HRX |
| Jul 18, 2000 | K001450 | AUTO SUTURE MICRO SURGICLIP CLIP APPLIER United States Surgical, A Division of Tyco Healthc | FZP |
| Mar 30, 2000 | K000037 | MONOFILAMENT BIOSYN SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Mar 10, 2000 | K000009 | SPIRAL RADIUS RODDING SYSTEM United States Surgical, A Division of Tyco Healthc | KWQ |
| Oct 27, 1999 | K992784 | NEXT GENERATION RODDING SYSTEM United States Surgical, A Division of Tyco Healthc | KWQ |
| Oct 5, 1999 | K993055 | DEXIDE BIPOLAR FORCEPS II** DEVICE United States Surgical, A Division of Tyco Healthc | GEI |
| Jun 23, 1999 | K991859 | DEXIDE BIPOLAR FORCEPS II ** DEVICE United States Surgical, A Division of Tyco Healthc | GEI |
| Jun 4, 1999 | K983296 | AUTO SUTURE ABBI SYSTEM United States Surgical, A Division of Tyco Healthc | KNW |
| Apr 1, 1999 | K990952 | NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES United States Surgical, A Division of Tyco Healthc | GAT |
| Apr 1, 1999 | K990951 | MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Feb 10, 1999 | K983400 | AUTO SUTURE SITE MARKER CLIP United States Surgical, A Division of Tyco Healthc | GDW |
| Jan 7, 1999 | K984438 | MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE United States Surgical, A Division of Tyco Healthc | FZP |
| Dec 30, 1998 | K984342 | ANTERIOR CERVICAL PLATING SYSTEM United States Surgical, A Division of Tyco Healthc | KWQ |
| Dec 22, 1998 | K983904 | ROGOZINSKI SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc | KWP |
| Dec 22, 1998 | K983899 | THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) United States Surgical, A Division of Tyco Healthc | KWQ |
| Dec 16, 1998 | K983293 | AUTO SUTURE LAPAROSCOPES DEVICE United States Surgical, A Division of Tyco Healthc | GCJ |
| Nov 6, 1998 | K982575 | MESH, SURGICAL, POLYMERIC United States Surgical, A Division of Tyco Healthc | FTL |
| Oct 26, 1998 | K983197 | SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) United States Surgical, A Division of Tyco Healthc | KWP |
| Jun 25, 1998 | K981935 | POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| May 20, 1998 | K980862 | TITANIUM SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc | MNH |
| May 11, 1998 | K981128 | SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc | GAP |
| Apr 25, 1998 | K972911 | AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER United States Surgical, A Division of Tyco Healthc | GAT |
| Mar 27, 1998 | K980124 | SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc | GAP |
| Mar 10, 1998 | K974734 | AURORA TITANIUM SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc | MNH |
| Feb 4, 1998 | K974213 | AURORA TITANIUM SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc | MNH |
| Dec 1, 1997 | K973496 | THE AUTO SUTURE* MIBB** SYSTEM United States Surgical, A Division of Tyco Healthc | KNW |
| Nov 10, 1997 | K965228 | FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE United States Surgical, A Division of Tyco Healthc | MAI |
| Nov 3, 1997 | K973281 | THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* United States Surgical, A Division of Tyco Healthc | MAI |
Newest 50 of 218.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||