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510(k) K792332

DAVOL/SIMON DERMATOME by Davol, Inc. — Product Code GFD

K792332 is an FDA 510(k) premarket notification submitted by Davol, Inc. for the device "DAVOL/SIMON DERMATOME". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code GFD (Dermatome), a Class I device regulated under 21 CFR 878.4820. Davol, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
November 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dermatome
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Davol, Inc.

  • K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped (June 12, 2025)
  • K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (April 9, 2025)
  • K031213 — AQUASENS FLUID MONITORING SYSTEM (April 30, 2003)
  • K030307 — DAVOL ARTHROVENT OUTFLOW TUBING (February 13, 2003)
  • K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (January 22, 2001)
  • K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, (December 22, 2000)
  • K931899 — DAVOL ATS (November 15, 1994)
  • K941334 — DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE (June 14, 1994)
  • K921405 — DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP (March 25, 1994)
  • K935503 — DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET (March 7, 1994)

Other clearances for product code GFD

  • K965256 — DMS-1000C DERMOABRADER (December 9, 1996)
  • K962371 — DERMTOME BLADE (August 29, 1996)
  • K945594 — DECA DERMATOME (MICROMOTOR SYSTEM) (June 5, 1995)
  • K951085 — PADGETT AIR DERMATOME, MODEL A (May 15, 1995)
  • K940208 — AESCULAP ACCU-DERMATOME (February 24, 1994)
  • K862669 — ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (October 3, 1986)
  • K861285 — SKIN MESH DEVICE (April 17, 1986)
  • K861138 — MASH DERMATOME (April 14, 1986)
  • K860925 — DERMASPANDERE (March 28, 1986)
  • K842702 — ROSENBERG SKIN GRAFTING KNIVES (August 2, 1984)

FDA data resources