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510(k) K933670

BIOPSY PUNCH, SURGICAL by Byron Medical — Product Code EME

K933670 is an FDA 510(k) premarket notification submitted by Byron Medical for the device "BIOPSY PUNCH, SURGICAL". The FDA issued a decision of Substantially Equivalent on January 7, 1994. The device falls under product code EME (Punch, Biopsy, Surgical), a Class I device regulated under 21 CFR 872.4565. Byron Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1994
Date Received
July 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Punch, Biopsy, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Byron Medical

  • K040149 — PSI-TEC PERISTALTIC INFILTRATION PUMP (June 3, 2004)
  • K001803 — ACCELERATOR RECIPROCATING CANNULA (August 4, 2000)
  • K981215 — PSI-TEC LIPOSUCTION ASPIRATOR (July 1, 1998)
  • K981172 — LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES (June 30, 1998)
  • K980738 — PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILT (June 16, 1998)
  • K980392 — PSI-TEC ASPIRATOR (March 5, 1998)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973133 — BIG BAG 3000 PRESSURE INFUSOR (September 12, 1997)
  • K934179 — DISPOSABLE BAG DECANTER (May 23, 1994)
  • K934233 — ZARA ZONE IV MALAR IMPLANT MODIFICATION (February 3, 1994)

Other clearances for product code EME

  • K911285 — PULPDENT POLYAMIDE DENTIN LINER (October 9, 1991)
  • K884740 — EURO-MED LIGHT TOUCH BIOPSY PUNCH (March 6, 1989)

FDA data resources