510(k) K942896
- Device
- CLAMPS AND CLIPS
- Applicant
- SURGIN SURGICAL INSTRUMENTATION, INC.
- 510(k) number
- K942896
- Product code
- MDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-07-19
- Date received
- 1994-06-20
- Regulation
- 878.4800
- Classification name
- Instrument, Manual, Surgical, General Use
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DON W HAAR
- Address
- 14762 Bentley Cir. Tustin CA US 92680 92680
FDA Registration Numbers#
- 3004513970
- 3010667733
- 9617601
- 3009540572
- 3005528784
- 1213649
- 3007515069
- 9610905
- 1063481
- 3006272282
- 3025603301
- 3010305275
- 3034669683
- 3008812251
- 8043404
- 9611274
- 9710649
- 3006795832
- 1320468
- 2245304
- 3003882387
- 3008843439
- 2182345
- 1047843
- 3005595283
- 3038718579
- 1724474
- 3001084743
- 3042624965
- 3029507159
- 3008936260
- 9615659
- 3010370554
- 9680143
- 3003860739
- 3010162782
- 3012329552
- 9611112
- 2529846
- 3042023934
- 9611502
- 3004024955
- 3006498370
- 3013421458
- 3020954746
- 3003032798
- 1923569
- 8010510
- 3027234828
- 2087382
- 3045855232
- 3044819802
- 3003661942
- 2080222
- 9610612
- 3007421149
- 3045817901
- 3011230048
- 3043606682
- 3011398162
- 1835831
- 3013683058
- 3014252644
- 3010405299
- 3016112537
- 3031564283
- 9681702
- 3015526995
- 3008808049
- 3005075853
- 3003988575
- 3011137372
- 3015231789
- 3010611926
- 8010300
- 3010845285
- 1055236
- 1000517406
- 3012755988
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MDM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | Injectimed, Inc. | 2008-08-08 |
| K050575 | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | Futumeds Sdn Bhd | 2005-08-15 |
| K050957 | EUTROCHAR | Special Devices, Inc. | 2005-05-18 |
| K023173 | ANDREWS INTRODUCER, MODEL ASI01 | Andrews Surgical Innovations, Ltd. | 2002-12-18 |
| K022059 | MICROVASIVE PULMONARY GUIDEWIRE | Boston Scientific Corp | 2002-11-13 |
| K013040 | LIGHT SABER INTRODUCER NEEDLE | Minrad, Inc. | 2001-12-07 |
| K010184 | CHESS HAND SURGERY SYSTEM | Canica Design, Inc. | 2001-06-22 |
| K990062 | SAPHLIFT | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-03-30 |
| K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | ETHICON, Inc. | 1998-07-09 |
| K943968 | TUNNELER | Denver Biomedicals, Inc. | 1995-03-01 |
| K945430 | DERMAVBLADE(TM) | Hasting'S Biomedical Corp. | 1994-11-28 |
| K941193 | EAST WEST INSTRUMENTS | East West Instruments, Inc. | 1994-11-09 |
| K941907 | APEX DISPOSABLE INSTRUMENTS | Apex Ent., Inc. | 1994-08-26 |
| K942818 | DEEP SUTURE | Automated Medical Products Corp. | 1994-08-25 |
| K940684 | SURGICAL INSTRUMENT, DISPOSABLE | Her-Mar, Inc. | 1994-03-14 |
Legacy Summary#
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FDA Review#
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