Panels › General, Plastic Surgery › Product code GDW · Class 2
Staple, Implantable
Regulation 878.4750
4510(k)s in 12 months (284 all time)
0recalls in 12 months (225 all time)
196recalls that name a 510(k)
Top companies in GDW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| 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 |
| Sep 30, 2003 | K032701 | SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) Power Medical Interventions, Inc. | GDW |
| Aug 21, 2003 | K032347 | BIOMARC TISSUE MARKER Carbon Medical Technologies, Inc. | GDW |
| May 15, 2003 | K030925 | PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 Ethicon Endo-Surgery, Inc. | GDW |
| Apr 22, 2003 | K024117 | INSORB ABSORBABLE STAPLES, MODEL SP-B20 Incisive Surgical, Inc. | GDW |
| Mar 31, 2003 | K030653 | SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS Power Medical Interventions, Inc. | GDW |
| Mar 20, 2003 | K030411 | PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03 Ethicon Endo-Surgery, Inc. | GDW |
| Mar 14, 2003 | K024275 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER United States Surgical, A Division of Tyco Healthc | GDW |
| Feb 3, 2003 | K023725 | HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 Marina Medical Instruments, Inc. | GDW |
| Dec 9, 2002 | K022313 | SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V Power Medical Interventions, Inc. | GDW |
| Nov 19, 2002 | K020804 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER United States Surgical, A Division of Tyco Healthc | GDW |
| Jun 21, 2002 | K021701 | SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 Power Medical Interventions, Inc. | GDW |
| Jun 5, 2002 | K020779 | PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS Ethicon Endo-Surgery, Inc. | GDW |
| May 15, 2002 | K021249 | SURGASSIST FLEXSHAFT 2, MODEL FS2 14 Power Medical Interventions, Inc. | GDW |
| May 10, 2002 | K020719 | SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES Power Medical Interventions, Inc. | GDW |
| Apr 10, 2002 | K020343 | SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL Power Medical Interventions, Inc. | GDW |
| Mar 8, 2002 | K014286 | SALUTE, MODEL 3022 Onux Medical, Inc. | GDW |
| Feb 11, 2002 | K013749 | ENDOANCHOR AND OPENANCHOR Ethicon Endo-Surgery, Inc. | GDW |
| Dec 19, 2001 | K013860 | AUTO SUTURE SURGICAL STAPLES United States Surgical, A Division of Tyco Healthc | GDW |
| Oct 26, 2001 | K012809 | SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 Power Medical Interventions, Inc. | GDW |
| Aug 23, 2001 | K012362 | MODIFICATION TO VASCULAR CLOSURE DEVICE Std Mfg., Inc. | GDW |
| May 3, 2001 | K001807 | TISSUE MARKER Advanced Uroscience, Inc. | GDW |
| Feb 13, 2001 | K003522 | SALUTE Onux Medical, Inc. | GDW |
| Dec 21, 2000 | K003277 | SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 Powermed, Inc. | GDW |
| Dec 8, 2000 | K003169 | VASCULAR CLOSURE DEVICE Std Mfg., Inc. | GDW |
| Dec 8, 2000 | K001895 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER United States Surgical, A Division of Tyco Healthc | GDW |
| Mar 27, 2000 | K000060 | GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007 Senorx, Inc. | GDW |
| Mar 7, 2000 | K000608 | SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM Std Mfg., Inc. | GDW |
| Feb 4, 2000 | K993785 | ULTRACLIP TISSUE MARKER Inrad | GDW |
| May 17, 1999 | K991030 | PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES Ethicon Endo-Surgery, Inc. | GDW |
| Mar 1, 1999 | K983318 | FIXATION SYSTEM General Surgical Innovations | GDW |
| Feb 10, 1999 | K983400 | AUTO SUTURE SITE MARKER CLIP United States Surgical, A Division of Tyco Healthc | GDW |
| Dec 18, 1998 | K983536 | PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS Ethicon Endo-Surgery, Inc. | GDW |
| Apr 9, 1998 | K980617 | MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER Urohealth Systems, Inc. | GDW |
| Sep 11, 1997 | K970817 | MICROMARK CLIP Biopsys Medical, Inc. | GDW |
| Oct 7, 1996 | K963015 | SURGICAL STAPLE MARKER DEVICE (MODIFY) Biopsys Medical, Inc. | GDW |
| Oct 3, 1995 | K952239 | AUTO SUTURE* MODIFIED LINEAR STAPLER** United States Surgical, A Division of Tyco Healthc | GDW |
| Mar 15, 1995 | K950006 | SURGICAL STAPLE MARKER Biopsys Medical, Inc. | GDW |
| Aug 24, 1994 | K942606 | SURGICAL STAPLE United States Surgical, A Division of Tyco Healthc | GDW |
| Oct 12, 1993 | K931103 | STRYKER STAPLER SYSTEM Stryker Endoscopy | GDW |
| Jul 8, 1993 | K931056 | DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING American Cyanamid Co. | GDW |
| Aug 6, 1992 | K922186 | HEM-O-LOK -- MODIFICATION Linvatec Corp. | GDW |
| Aug 6, 1992 | K920752 | ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER ETHICON, Inc. | GDW |
| Jul 16, 1992 | K921051 | 3M PRECISE BRAND INTERNAL SURGICAL STAPLES 3M Health Care, Ltd. | GDW |
| Mar 19, 1992 | K915693 | PROXIMATE ABSORBABLE STAPLES ETHICON, Inc. | GDW |
| Jan 31, 1992 | K915489 | AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE United States Surgical, A Division of Tyco Healthc | GDW |
| Oct 17, 1991 | K914130 | AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES United States Surgical, A Division of Tyco Healthc | GDW |
| Oct 17, 1991 | K913832 | AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER United States Surgical, A Division of Tyco Healthc | GDW |
| Oct 17, 1991 | K913802 | AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER United States Surgical, A Division of Tyco Healthc | GDW |
| Sep 25, 1991 | K913211 | AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER United States Surgical, A Division of Tyco Healthc | GDW |
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