510(k) K854541
- Device
- TIP OFF FORCEPS
- Applicant
- KELLER INSTRUMENTS, INC.
- 510(k) number
- K854541
- Product code
- GEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-12-17
- Date received
- 1985-11-13
- 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
- EUGENE VANARSDALE
- Address
- 456 Pkwy. Broomall PA US 19008 19008
FDA Registration Numbers#
- 3006487092
- 1423537
- 9614986
- 8010769
- 3006563559
- 3006538822
- 1519132
- 3015512299
- 3013194153
- 9611262
- 3005809810
- 3008953712
- 3017417635
- 3036795921
- 3016248634
- 1055890
- 3012656745
- 2936485
- 1450019
- 1421101
- 3015895045
- 9680059
- 3021680161
- 1054241
- 1226486
- 1928237
- 3002808270
- 3010097171
- 3003696170
- 8010273
- 1032347
- 1220477
- 8040179
- 3007728276
- 3010455030
- 3002675176
- 3010055973
- 3032109
- 1422598
- 8043507
- 3009417901
- 2085947
- 3007597038
- 3004598675
- 3008797953
- 8010300
- 3002807115
- 2126670
- 2084346
- 3003803182
- 3005621335
- 3002761766
- 3006142527
- 2083373
- 9611367
- 3004911384
- 8040263
- 9680304
- 1061124
- 3005440795
- 1038758
- 3007518347
- 1926681
- 1935627
- 3008338766
- 1422443
- 1828464
- 2320762
- 9611610
- 3003431869
- 3004215117
- 3008023310
- 3034688516
- 3029082594
- 2916714
- 3004705187
- 8010456
- 9616538
- 3005973280
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases