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510(k) K990062

SAPHLIFT by Genzyme Surgical Product (Genzyme Biosurgery) — Product Code MDM

K990062 is an FDA 510(k) premarket notification submitted by Genzyme Surgical Product (Genzyme Biosurgery) for the device "SAPHLIFT". The FDA issued a decision of Substantially Equivalent on March 30, 1999. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Genzyme Surgical Product (Genzyme Biosurgery) has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1999
Date Received
January 8, 1999
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 Genzyme Surgical Product (Genzyme Biosurgery)

  • K001440 — NEXTSTITCH CARDIOVASCULAR VALVE SUTURE (November 13, 2000)
  • K001434 — 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGIC (June 12, 2000)
  • K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (September 3, 1999)
  • K991416 — ENDOSCOPIC CAMERA (July 20, 1999)
  • K991191 — BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (June 22, 1999)
  • K982712 — RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 (December 18, 1998)
  • K980016 — MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (August 7, 1998)
  • K981322 — CUTALON NYLON POLYAMIDE SURGICAL SUTURE (July 7, 1998)

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)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K943968 — TUNNELER (March 1, 1995)
  • K945430 — DERMAVBLADE(TM) (November 28, 1994)

FDA data resources