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510(k) K881638

SURGICAL BLADE by Far East Intl. Trading Corp. — Product Code GES

K881638 is an FDA 510(k) premarket notification submitted by Far East Intl. Trading Corp. for the device "SURGICAL BLADE". The FDA issued a decision of Substantially Equivalent on June 15, 1988. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Far East Intl. Trading Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1988
Date Received
April 14, 1988
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 Far East Intl. Trading Corp.

  • K881937 — SURGICAL INSTRUMENTS (June 15, 1988)

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)
  • K880244 — SURGICAL BLADES (February 10, 1988)
  • K873493 — NINJA SCALPEL (September 24, 1987)
  • K873142 — PERSONNA DISPOSABLE SCALPEL (September 4, 1987)

FDA data resources