510(k) K901107
- Device
- MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
- Applicant
- UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
- 510(k) number
- K901107
- Product code
- GDJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-09
- Date received
- 1990-03-08
- Regulation
- 878.4800
- Classification name
- Clamp, Surgical, General & Plastic Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHEN REITZLER
- Address
- 150 Glover Ave. Norwalk CT US 06856 06856
FDA Registration Numbers#
- 3006487092
- 1423537
- 3017540705
- 9681860
- 9614093
- 3015451162
- 2183785
- 3006538822
- 9610612
- 8043441
- 3015398570
- 9680837
- 2244478
- 3022747125
- 3014334038
- 3015512299
- 8010704
- 1423662
- 9611579
- 3004986960
- 8043496
- 9616250
- 2431166
- 1625425
- 3005809810
- 3009590742
- 3036795921
- 3009255580
- 1055890
- 2184009
- 3015177648
- 1420054
- 3009865268
- 9613910
- 3005067367
- 3002976036
- 9616088
- 3018094310
- 1421101
- 3015895045
- 3016696686
- 9680059
- 2424531
- 3004371426
- 3014207283
- 9681540
- 3005695838
- 3004608878
- 3007410669
- 1054241
- 9610621
- 2647580
- 3003597504
- 8010422
- 1123010
- 3002808270
- 3005911383
- 3010097171
- 9680260
- 3003696170
- 3004001706
- 9680411
- 2246990
- 8010273
- 3016994953
- 1032347
- 9611102
- 1219930
- 1648571
- 9710524
- 3011371465
- 3016069968
- 3006846581
- 3005061536
- 8040179
- 3042248499
- 3010455030
- 3008812560
- 1058726
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153358 | Standard Clamp | Standard Bariatrics | 2016-05-02 |
| K930315 | THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE | Thomasville Medical Assoc. | 1994-02-04 |
| K924223 | MAR-MED LIVER STRAP | Mar-Med Co. | 1993-03-18 |
| K922659 | GENERAL SURGERY CLAMP AND NEEDLE HOLDER | Miltex Instrument Co. | 1992-07-21 |
| K914913 | GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST | Ideal Medical, Inc. | 1991-12-31 |
| K900956 | GS-7100 CHOLANGIOGRAM CLAMP, 5MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K895726 | VESSEL OCCLUDER | Applied Medical Technologies | 1989-10-24 |
| K895591 | SILICONE INSTRUMENT SHODS | Key Surgical, Inc. | 1989-10-20 |
| K882169 | SURGICAL DUCT CLAMP (VINE) | Henley Intl. | 1988-06-17 |
| K881741 | STUART LEE CLIP | Stuart-Lee, Inc. | 1988-06-03 |
| K881084 | UTILITY CLAMP | Med-Dex Intl. | 1988-03-25 |
| K874428 | AUTO SUTURE PURSE STRING APPLIER* | United States Surgical, A Division of Tyco Healthc | 1987-12-02 |
| K855144 | TOURIQUET KIT WITH SNARE | Dlp, Inc. | 1986-02-05 |
| K853583 | MODERN MEDICAL PRODUCTS TOWEL CLAMP | Modern Medical Products | 1985-09-16 |
| K852724 | BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-15 |
Legacy Summary#
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FDA Review#
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