510(k) K873176
- Device
- Huffman Biopsy Unit
- Applicant
- PENN MEDICAL DEVICES, INC.
- 510(k) number
- K873176
- Product code
- FCL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-14
- Date received
- 1987-08-12
- Regulation
- 876.1075
- Classification name
- Forceps, Biopsy, Non-Electric
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES E MEISCH
- Address
- 12 Ridge St. Basking Ridge NJ US 07920 07920
FDA Registration Numbers#
- 3042225166
- 3008274780
- 3010612620
- 3035708926
- 3008808049
- 3031240334
- 9611814
- 3027454635
- 3013011598
- 3005941719
- 3009881188
- 3011600579
- 8043746
- 1000121056
- 1222168
- 8030607
- 3011707784
- 2020550
- 1320894
- 3043141270
- 1223925
- 3005987240
- 3035710892
- 3001845648
- 9680770
- 3044883001
- 3011137372
- 9616250
- 3018116884
- 8040278
- 3011570296
- 8010370
- 3008808042
- 3020984207
- 3014620201
- 9611616
- 3004215117
- 3005809810
- 9680515
- 3003687489
- 3016696686
- 3008911114
- 3010515547
- 9617744
- 8010487
- 3004777218
- 9611112
- 1056129
- 3009438115
- 8010298
- 3020746799
- 9611102
- 3010699884
- 3017616393
- 3008693678
- 3008902714
- 3043532714
- 2183446
- 8043441
- 3009526575
- 3006546082
- 3009169953
- 3013526170
- 1820334
- 3015895045
- 1421879
- 3014342096
- 3029929134
- 3007878094
- 1836161
- 3016789487
- 3013784566
- 3006975595
- 3013388519
- 3033434906
- 8010395
- 3004361445
- 3008252486
- 8010099
- 3004001706
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE | Olympus Optical Co., Ltd. | 2003-07-16 |
| K973611 | SPECTRASCIENCE REUSABLE BIOPSY FORCEPS | Spectrascience, Inc. | 1997-12-02 |
| K971315 | AUXILIARY INSTRUMENTS FOR URS | Richard Wolf Medical Instruments Corp. | 1997-09-15 |
| K964120 | INJECTO FLUSH | Robert J. Jynch, Jr. | 1996-12-30 |
| K963517 | SPECTRA SCIENCE BIOPSY FORCEPS | Spectrascience, Inc. | 1996-12-02 |
| K955065 | OLYMPUS FB SERIES BIOPSY FORCEPS | Olympus America, Inc. | 1996-01-24 |
| K952863 | FORCEPS, BIOPSY, NON-ELECTRIC | Annex Medical, Inc. | 1995-07-19 |
| K952391 | DYNABITE UROLOGICAL FORCEPS | Portlyn Corp. | 1995-06-01 |
| K951048 | RITE-BITE BIOPSY FORCEPS | Mill-Rose Laboratory | 1995-03-15 |
| K946360 | MODULAR BIOPSY FORCEP | Cox Medical Ent., Inc. | 1995-03-06 |
| K950559 | DIENER RETRIEVAL DEVICES | Mill-Rose Laboratory | 1995-02-16 |
| K946238 | SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS | Symbiosis Corp. | 1995-01-20 |
| K944770 | LSVP INTERNATIONAL BIOPSY FORCEPS | Lsvp Intl., Inc. | 1994-10-13 |
| K941816 | EMC FLEXIBLE BIOPSY FORCEPS | Enterprise Medical Corp. | 1994-07-13 |
| K941359 | GIP/MEDI-GLOBE BIOPSY FORCEPS | Medi-Globe Corp. | 1994-07-12 |