510(k) K812205
- Device
- FORCEP
- Applicant
- REZNIK INSTRUMENTS
- 510(k) number
- K812205
- Product code
- GEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-26
- Date received
- 1981-08-04
- Regulation
- 878.4800
- Classification name
- Forceps, 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1000175697
- 3036037316
- 3021519357
- 1526534
- 3003882387
- 1315756
- 8043404
- 3009865268
- 3043355002
- 3005809810
- 3005641619
- 3007024186
- 3015451162
- 9613079
- 3014201171
- 8043769
- 3010202439
- 8010269
- 9611112
- 3002808270
- 3001620590
- 3007518347
- 1055890
- 3003675041
- 3009513193
- 3010269591
- 3011767135
- 3035678069
- 9617297
- 3011585752
- 3009468807
- 9611610
- 8010890
- 3043226252
- 3008992312
- 9680519
- 3002090132
- 3013011598
- 3016450032
- 9681129
- 3008676146
- 3013503739
- 8010343
- 3029082594
- 1932214
- 9615005
- 1055236
- 9611367
- 8040172
- 3032391
- 1319660
- 1423625
- 1216677
- 3012494290
- 3043533459
- 3006563559
- 1450019
- 3008023310
- 3003877407
- 8010591
- 3015177648
- 3003322138
- 8010518
- 3005813597
- 9681161
- 3004001706
- 1935627
- 8030973
- 3009394448
- 8010099
- 3004608878
- 3013784566
- 3002862271
- 3006846581
- 1423537
- 5906
- 3014054118
- 3005083075
- 3004598675
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031828 | NATURALASE LP ND:YAG LASER | Focus Medical, LLC | 2003-07-17 |
| K953962 | FORCEPS | Biopsys Medical, Inc. | 1995-09-08 |
| K932385 | SUTURE REMOVING FORCEPS | Rocket of London, Ltd. | 1993-08-06 |
| K904723 | FORCEPS | Minto Research & Development, Inc. | 1991-07-26 |
| K911159 | PALPATION PROBE | Northgate Technologies, Inc. | 1991-03-29 |
| K900960 | GS-1500 CLAW FORCEP, 10MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900951 | GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP | Solos Endoscopy, Inc. | 1990-04-18 |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | Solos Endoscopy, Inc. | 1990-04-18 |
| K891896 | TISSUE FORCEPS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K891401 | HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT | Zinnanti Surgical Instruments, Inc. | 1989-04-06 |
| K891348 | CAMPION LASER FORCEPS | Simpson/Basye, Inc. | 1989-03-22 |
| K884514 | FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL | Gatewood and Associates, Ltd. | 1988-11-17 |
| K884181 | MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS) | Sales & Marketing Assoc. | 1988-11-10 |
| K884195 | GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) | Mumtaz I. Malik | 1988-10-24 |
Legacy Summary#
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FDA Review#
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