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510(k) K953128

SUTURE CORD by Phoenix Biomedical Corp. — Product Code GAS

K953128 is an FDA 510(k) premarket notification submitted by Phoenix Biomedical Corp. for the device "SUTURE CORD". The FDA issued a decision of SN on February 9, 1996. The device falls under product code GAS (Suture, Nonabsorbable, Synthetic, Polyester), a Class II device regulated under 21 CFR 878.5000. Phoenix Biomedical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
February 9, 1996
Date Received
July 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyester
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Phoenix Biomedical Corp.

  • K033017 — PHOENIX INFUSION CATHETER (April 7, 2004)
  • K030468 — ACURA ELITE GRAVITY COMPENSATING RESERVOIR (October 15, 2003)
  • K024101 — PHOENIX UNIVERSAL SHUNT SYSTEM (January 27, 2003)
  • K024040 — ACCURA ELITE SHUNT SYSTEM (January 27, 2003)
  • K021644 — PERF (OMMAYA STYLE) RESERVOIRS (August 6, 2002)
  • K002476 — LUMBOPERITONEAL SHUNT SYSTEM (November 9, 2000)
  • K000514 — RUMBAR DRAINAGE SYSTEM (May 10, 2000)
  • K991429 — DIAMOND II VALVE (May 19, 1999)
  • K990256 — CRX WORLD SHUNT (April 1, 1999)
  • K974096 — CRX DIAMOND VALVE (December 8, 1998)

Other clearances for product code GAS

  • K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK (November 24, 2020)
  • K203081 — RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (November 24, 2020)
  • K091018 — ARTHREX BIOWIRE (July 30, 2010)
  • K002261 — MR-III (October 23, 2000)
  • K923161 — BRAIDED POLYESTER SUTURE MATERIAL (December 30, 1992)
  • K913101 — PETERS CARDIOFLON(TM) SUTURE (August 12, 1992)
  • K915089 — MITEK QUICKANCHOR(TM), MODIFICATION (February 3, 1992)
  • K915081 — MITEK SNAP PAK(TM), MODIFICATION (January 31, 1992)
  • K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (July 26, 1991)
  • K905285 — IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (February 11, 1991)

FDA data resources