Home / 510(k) Clearances / K812814

510(k) K812814

ZEE SURGICAL INSTRUMENTS by Zee Medical Products Co., Inc. — Product Code GDZ

K812814 is an FDA 510(k) premarket notification submitted by Zee Medical Products Co., Inc. for the device "ZEE SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on November 6, 1981. The device falls under product code GDZ (Handle, Scalpel), a Class I device regulated under 21 CFR 878.4800. Zee Medical Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1981
Date Received
October 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Zee Medical Products Co., Inc.

  • K823501 — ZEE SPHYGMOMANOMETER (January 21, 1983)
  • K813156 — ULTRA-WIDE SAFETY SPECTACLE FRAME (December 14, 1981)
  • K813016 — ZEE TRACTION SPLINT (November 24, 1981)
  • K812564 — ZEE LIFE SUPPORT AIR PANTS (October 23, 1981)
  • K812342 — ZEE EXTRICATION DEVICE (September 21, 1981)
  • K812284 — ZEE ELECTRODE-GEL (September 8, 1981)
  • K812022 — ZEE MANUAL RESUSCITATOR (July 31, 1981)

Other clearances for product code GDZ

  • K091462 — SPECTRA MEDICAL SAFETY SCAPEL (December 15, 2009)
  • K890242 — SCALPEL HANDLE (January 27, 1989)
  • K884512 — BEAVER(R) HANDLE (November 17, 1988)
  • K863951 — P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE (October 24, 1986)
  • K863808 — THE S. CORDERO STYLUS (October 14, 1986)
  • K863212 — KEISEI HANDLES FOR SURGICAL BLADES (September 2, 1986)
  • K854858 — SCALPEL HANDLE (December 24, 1985)
  • K852711 — SCALPEL HANDLE #3 SS 410 OR 420 (July 15, 1985)
  • K852735 — SCALPEL HANDLE #7 SS 410 OR 420 (July 15, 1985)
  • K851750 — 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 (June 20, 1985)

FDA data resources