Home / 510(k) Clearances / K921988

510(k) K921988

LACERATION REPAIR TRAY by Cypress Medical Products, Ltd. — Product Code MDM

K921988 is an FDA 510(k) premarket notification submitted by Cypress Medical Products, Ltd. for the device "LACERATION REPAIR TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 19, 1992. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Cypress Medical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
November 19, 1992
Date Received
April 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Cypress Medical Products, Ltd.

  • K021676 — CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL (July 12, 2002)
  • K012282 — STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (August 6, 2001)
  • K972899 — CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER (July 7, 1998)
  • K972849 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (May 28, 1998)
  • K972883 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (February 26, 1998)
  • K952367 — CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE (July 5, 1995)
  • K950254 — CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE (March 31, 1995)
  • K950092 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY (February 27, 1995)
  • K950109 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER (February 27, 1995)
  • K945082 — CYPRESS MEDICAL PRODUCTS STETHOSCOPE (December 8, 1994)

Other clearances for product code MDM

  • K073664 — FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (August 8, 2008)
  • K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (August 15, 2005)
  • K050957 — EUTROCHAR (May 18, 2005)
  • K023173 — ANDREWS INTRODUCER, MODEL ASI01 (December 18, 2002)
  • K022059 — MICROVASIVE PULMONARY GUIDEWIRE (November 13, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (December 7, 2001)
  • K010184 — CHESS HAND SURGERY SYSTEM (June 22, 2001)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K943968 — TUNNELER (March 1, 1995)

FDA data resources