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510(k) K896147

BIOPSY FORCEP (NON-ELECTRIC) by Portlyn Corp. — Product Code FCL

K896147 is an FDA 510(k) premarket notification submitted by Portlyn Corp. for the device "BIOPSY FORCEP (NON-ELECTRIC)". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Portlyn Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
October 23, 1989
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 Portlyn Corp.

  • K970083 — DYNABITE HOT GI BIOPSY FORCEPS (June 17, 1997)
  • K951447 — DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (July 27, 1995)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K944245 — DYNABITE LAPAROSCOPIC FORCEPS (November 15, 1994)
  • K934506 — DYNABITE HYSTEROSCOPIC FORCEPS (March 22, 1994)
  • K901300 — BIOPSY FORCEPS (June 29, 1990)
  • K896146 — BIOPSY FORCEPS, (NON-RIGID) (March 9, 1990)

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