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510(k) K873176

HUFFMAN BIOPSY UNIT by Penn Medical Devices, Inc. — Product Code FCL

K873176 is an FDA 510(k) premarket notification submitted by Penn Medical Devices, Inc. for the device "HUFFMAN BIOPSY UNIT". The FDA issued a decision of Substantially Equivalent on October 14, 1987. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Penn Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1987
Date Received
August 12, 1987
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 Penn Medical Devices, Inc.

  • K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY (October 20, 1987)
  • K873177 — DEVINE (SUPRAPUBIC SOUND AND GUIDE) (October 14, 1987)
  • K873178 — URETERAL BULB DILATORS (September 30, 1987)
  • K871667 — URETERAL STENT (June 10, 1987)
  • K870508 — GASTROINTESTINAL TUBE (May 11, 1987)
  • K862729 — PENN 3-RING HANDLE (October 24, 1986)
  • K862107 — PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR (September 11, 1986)

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