510(k) K853015
- Device
- Self-centering Bone Holding Forceps, 10-1/4 Ss420
- Applicant
- THE HUXLEY INSTRUMENT CORP.
- 510(k) number
- K853015
- Product code
- GEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-07-29
- Date received
- 1985-07-17
- 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#
- Contact
- REBECCA J SHAHZADA
- Address
- 215 Main St. Penn Yan NY US 14527 14527
FDA Registration Numbers#
- 3008953712
- 3043355002
- 3022862651
- 3007648354
- 3013497507
- 8040884
- 8043404
- 1926681
- 3003541440
- 3003803182
- 3005813597
- 9615005
- 3015212339
- 3035678069
- 3003418325
- 3012226300
- 1720747
- 3007518347
- 8010298
- 3008280196
- 9611062
- 9616250
- 3013226
- 3004133929
- 3005440795
- 8010300
- 8010591
- 1422443
- 8040278
- 2431425
- 3023191945
- 3030451558
- 8040881
- 3007407626
- 3005897698
- 3010269591
- 8010877
- 3045816902
- 9680519
- 8010890
- 3036795921
- 3004598675
- 3009513193
- 3012267976
- 3015399803
- 9613926
- 2249529
- 3000126234
- 3031240334
- 3013946322
- 3004111573
- 3009865268
- 3001084743
- 3030516433
- 2953119
- 3000286616
- 3012995405
- 1058726
- 3005761322
- 1058020
- 3008492462
- 3017521423
- 8010607
- 8021788
- 3011715922
- 8010273
- 3004608878
- 3009931872
- 3008902714
- 9680837
- 3010055973
- 3010705004
- 1043214
- 9614986
- 1522875
- 3010687973
- 3008388427
- 2023918
- 3003675041
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 |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | Solos Endoscopy, Inc. | 1990-04-18 |
| K900951 | GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP | Solos Endoscopy, Inc. | 1990-04-18 |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900960 | GS-1500 CLAW FORCEP, 10MM | 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 |