Spectrascience Reusable Biopsy Forceps
FDA 510(k) K973611 · Spectrascience, Inc.
510(k) numberK973611
Submission
- Device name
- Spectrascience Reusable Biopsy Forceps
- Applicant
- Spectrascience, Inc.
Minneapolis, MN, US - Received
- September 22, 1997
- Decision date
- December 2, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCL – Forceps, Biopsy, Non-Electric
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032092 | Olympus XCYF-TP3 Cystofiberscope/NephrofiberscopeFCL · Traditional | Olympus Optical Co., Ltd. | 07/16/2003SE |
| K971315 | Auxiliary Instruments for UrsFCL · Traditional | Richard Wolf Medical Instruments Corp. | 09/15/1997SE |
| K964120 | Injecto FlushFCL · Traditional | Robert J. Jynch, Jr. | 12/30/1996SE |
| K963517 | Spectra Science Biopsy ForcepsFCL · Traditional | Spectrascience, Inc. | 12/02/1996SE |
| K955065 | Olympus FB Series Biopsy ForcepsFCL · Traditional | Olympus America, Inc. | 01/24/1996SE |
| K952863 | Forceps, Biopsy, Non-ElectricFCL · Traditional | Annex Medical, Inc. | 07/19/1995SE |
| K952391 | Dynabite Urological ForcepsFCL · Traditional | Portlyn Corp. | 06/01/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | Mill-Rose Laboratory | 03/15/1995SE |
| K946360 | Modular Biopsy ForcepFCL · Traditional | Cox Medical Ent., Inc. | 03/06/1995SE |
| K950559 | Diener Retrieval DevicesFCL · Traditional | Mill-Rose Laboratory | 02/16/1995SE |
More from Mill-Rose Laboratory
| 510(k) | Device | Decision |
|---|---|---|
| K963517 | Spectra Science Biopsy ForcepsFCL · Traditional | 12/02/1996SE |
Questions and answers
When was Spectrascience Reusable Biopsy Forceps cleared by the FDA?
Spectrascience Reusable Biopsy Forceps (K973611) received a 510(k) decision of Substantially Equivalent on December 2, 1997, 71 days after the submission was received.
What is the product code of K973611?
The FDA product code is FCL – Forceps, Biopsy, Non-Electric, a Class I (low risk) device regulated under 21 CFR 876.1075.