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510(k) K933516

ACU-E PUNCH by Acuderm, Inc. — Product Code LRY

K933516 is an FDA 510(k) premarket notification submitted by Acuderm, Inc. for the device "ACU-E PUNCH". The FDA issued a decision of Substantially Equivalent on March 24, 1994. The device falls under product code LRY (Punch, Surgical), a Class I device regulated under 21 CFR 878.4800. Acuderm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1994
Date Received
July 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Punch, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Acuderm, Inc.

  • K933265 — ACU-DISPO-CE(TM) (March 7, 1994)
  • K933137 — ACU-SUTURE KIT (February 22, 1994)
  • K930043 — ACU-EVAC (February 9, 1994)
  • K933866 — ACU-HEMOSTATIC RING (December 1, 1993)
  • K915000 — ACU-GUARD (January 27, 1992)
  • K891334 — ACU-CURETTE (April 11, 1989)
  • K874024 — ACU-MICRO-NEEDLE (November 23, 1987)
  • K854877 — ACU-SYRINGE W/WO NEEDLES (February 19, 1986)
  • K832583 — SABOURAUD DEXTROSE AGAR (September 12, 1983)
  • K832582 — MYCOSEL AGAR (September 12, 1983)

Other clearances for product code LRY

  • K904869 — ELLIPSE PUNCH (March 6, 1991)
  • K902636 — LIPOGEN RHEUMELISA DSDNA ASSAY (June 28, 1990)
  • K896303 — BIOPSY PUNCH (February 13, 1990)
  • K874356 — PIN PUNCH (November 23, 1987)
  • K874357 — TAPERED PUNCH (November 23, 1987)
  • K872388 — NAIL SET (July 23, 1987)

FDA data resources