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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 Mar 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 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 30, 1999
Date Received
Jan 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
510(k) Exempt

Other clearances by Genzyme Surgical Product (Genzyme Biosurgery)

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

Other clearances for product code MDM

  • K073664 — FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (Aug 8, 2008)
  • K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (Aug 15, 2005)
  • K050957 — EUTROCHAR (May 18, 2005)
  • K023173 — ANDREWS INTRODUCER, MODEL ASI01 (Dec 18, 2002)
  • K022059 — MICROVASIVE PULMONARY GUIDEWIRE (Nov 13, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (Dec 7, 2001)
  • K010184 — CHESS HAND SURGERY SYSTEM (Jun 22, 2001)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (Jul 9, 1998)
  • K943968 — TUNNELER (Mar 1, 1995)
  • K945430 — DERMAVBLADE(TM) (Nov 28, 1994)

FDA data resources