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510(k) K933135

DAWN DISPOSABLE BIOPSY FORCEPS by Dawn Medical — Product Code FCL

K933135 is an FDA 510(k) premarket notification submitted by Dawn Medical for the device "DAWN DISPOSABLE BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Dawn Medical has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
June 28, 1993
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 Dawn Medical

  • K904117 — SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. (February 25, 1991)
  • K904118 — SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. (February 25, 1991)
  • K905733 — SEROMA-CATH CLOSE DRAINAGE SYSTEM (January 28, 1991)

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