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510(k) K810572

BLADE, HANDLE, SCALPEL FORCEPS, SURGERY by Technical Resources, Inc. — Product Code GES

K810572 is an FDA 510(k) premarket notification submitted by Technical Resources, Inc. for the device "BLADE, HANDLE, SCALPEL FORCEPS, SURGERY". The FDA issued a decision of Substantially Equivalent on March 20, 1981. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Technical Resources, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1981
Date Received
March 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Technical Resources, Inc.

  • K792473 — THERAPETTE, MODEL NO MH-100 (December 20, 1979)
  • K790805 — DRUG ABUSE DIPSTICKS (June 6, 1979)

Other clearances for product code GES

  • K032242 — PERSONNA PLUS SAFETY SCALPEL SYSTEM (September 23, 2003)
  • K932998 — EASY-ON (August 18, 1993)
  • K923170 — LOS ALAMOS RETRACTABLE KNIFE (February 18, 1993)
  • K915119 — SCALPEL BLADE REMOVER (BLADEGARD) (May 5, 1992)
  • K911913 — PRECISION GLIDE - ENHANCED SURGICAL BLADE (May 13, 1991)
  • K900266 — STERILE CARBON STEEL SURGICAL BLADE (March 1, 1990)
  • K884862 — ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (December 27, 1988)
  • K881638 — SURGICAL BLADE (June 15, 1988)
  • K880244 — SURGICAL BLADES (February 10, 1988)
  • K873493 — NINJA SCALPEL (September 24, 1987)

FDA data resources