Home / 510(k) Clearances / K770933

510(k) K770933

BIO-SHIELD CSR WRAP by Convertors — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1977
Date Received
May 23, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Convertors

  • K780627 — SURG-O-PAK, GOWNS, SHEETS, AND TOWELS (July 11, 1979)
  • K790234 — DRAPE PACKS, SURGICAL GOWNS (February 22, 1979)
  • K781959 — SURGICAL GOWNS, SHEETS (January 10, 1979)
  • K781534 — SURG-O-PAK PREP PAD (October 24, 1978)
  • K781099 — SURGICAL GOWNS AND DRAPES (August 14, 1978)
  • K780169 — MASK, SURGICAL (February 13, 1978)
  • K771929 — PEDIATRICS GOWN (November 16, 1977)
  • K770346 — ORTHOPEDIC STOCKINETTE (March 7, 1977)
  • K761034 — SURGEX SURGICAL SPONGE (January 5, 1977)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)