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510(k) K884862

ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE by Anchor Products Co. — Product Code GES

K884862 is an FDA 510(k) premarket notification submitted by Anchor Products Co. for the device "ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE". The FDA issued a decision of Substantially Equivalent on December 27, 1988. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Anchor Products Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1988
Date Received
November 21, 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 Anchor Products Co.

  • K091930 — ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB (September 23, 2009)
  • K061555 — ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM (August 31, 2006)
  • K982073 — ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM (September 22, 1998)
  • K873124 — ANCHOR BIOPSY NEEDLE (September 8, 1987)
  • K831648 — ANCHOR BRAND SURGICAL NEEDLES (August 16, 1983)
  • K790405 — ANCHOR BRAND COUNT-TAINER (March 26, 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)
  • K881638 — SURGICAL BLADE (June 15, 1988)
  • K880244 — SURGICAL BLADES (February 10, 1988)
  • K873493 — NINJA SCALPEL (September 24, 1987)
  • K873142 — PERSONNA DISPOSABLE SCALPEL (September 4, 1987)

FDA data resources