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510(k) K941816

EMC FLEXIBLE BIOPSY FORCEPS by Enterprise Medical Corp. — Product Code FCL

K941816 is an FDA 510(k) premarket notification submitted by Enterprise Medical Corp. for the device "EMC FLEXIBLE BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on July 13, 1994. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Enterprise Medical Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1994
Date Received
April 13, 1994
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 Enterprise Medical Corp.

  • K942431 — LAPOROSCOPIC SCISSORS (October 11, 1995)
  • K943583 — KERRISON RONGEURS (February 21, 1995)

Other clearances for product code FCL

  • K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
  • K973611 — SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (December 2, 1997)
  • 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)

FDA data resources