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510(k) K973611

SPECTRASCIENCE REUSABLE BIOPSY FORCEPS by Spectrascience, Inc. — Product Code FCL

K973611 is an FDA 510(k) premarket notification submitted by Spectrascience, Inc. for the device "SPECTRASCIENCE REUSABLE BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on December 2, 1997. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Spectrascience, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1997
Date Received
September 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Non-Electric
Device Class
Class I
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Spectrascience, Inc.

  • K963517 — SPECTRA SCIENCE BIOPSY FORCEPS (December 2, 1996)

Other clearances for product code FCL

  • K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
  • K971315 — AUXILIARY INSTRUMENTS FOR URS (September 15, 1997)
  • K964120 — INJECTO FLUSH (December 30, 1996)
  • K963517 — SPECTRA SCIENCE BIOPSY FORCEPS (December 2, 1996)
  • K955065 — OLYMPUS FB SERIES BIOPSY FORCEPS (January 24, 1996)
  • K952863 — FORCEPS, BIOPSY, NON-ELECTRIC (July 19, 1995)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)
  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)
  • K950559 — DIENER RETRIEVAL DEVICES (February 16, 1995)

FDA data resources