510(k) K963517
- Device
- SPECTRA SCIENCE BIOPSY FORCEPS
- Applicant
- SPECTRASCIENCE, INC.
- 510(k) number
- K963517
- Product code
- FCL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-12-02
- Date received
- 1996-09-03
- Regulation
- 876.1075
- Classification name
- Forceps, Biopsy, Non-electric
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN MCMAHON
- Address
- 5909 Baker Rd., Suite 580 Minnetonka MN US 55345 55345
FDA Registration Numbers#
- 9611616
- 3003687489
- 3023657851
- 9611112
- 3011193403
- 3029929134
- 8043746
- 3005440795
- 3010138349
- 3003902943
- 3004215117
- 2431166
- 8010370
- 8010282
- 9610617
- 8010047
- 3005580113
- 3017103427
- 1421879
- 1061124
- 3004837686
- 3033434906
- 3013337852
- 8040278
- 2183446
- 8010099
- 3010041511
- 1923569
- 3006161756
- 3015142721
- 8010769
- 3010131466
- 9680488
- 3006621103
- 1315756
- 3008911114
- 9611283
- 1000121056
- 3008048800
- 3020746799
- 3013011598
- 3008040402
- 3003759558
- 3010455030
- 3010699884
- 3010707607
- 3015895045
- 3004962788
- 2124215
- 8010343
- 3008808049
- 3004083736
- 3008274780
- 3001620590
- 8010487
- 3009526575
- 3042225166
- 9611680
- 3020984207
- 3013440400
- 3006975595
- 3004001706
- 3016994953
- 1836161
- 3021023752
- 3010273867
- 3029082594
- 1223925
- 3012042439
- 3011050570
- 3035708926
- 9680515
- 3012322232
- 3015970743
- 3017178358
- 2529846
- 3009881188
- 3010273872
- 1820334
Source Documents#
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 |
| 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 |
| K933135 | DAWN DISPOSABLE BIOPSY FORCEPS | Dawn Medical | 1994-03-07 |
Legacy Summary#
summary
FDA Review#
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