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510(k) K802726

INSTRUMENTS NONSTERILE & STERILE by Ascep, Inc. — Product Code HAO

K802726 is an FDA 510(k) premarket notification submitted by Ascep, Inc. for the device "INSTRUMENTS NONSTERILE & STERILE". The FDA issued a decision of Substantially Equivalent on Nov 19, 1980. The device falls under product code HAO (Instrument, Surgical, Non-Powered), a Class I device regulated under 21 CFR 882.4535. Ascep, Inc. has 8 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 19, 1980
Date Received
Oct 27, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type
510(k) Exempt

Other clearances by Ascep, Inc.

  • K830219 — VARIOUS INSTRUMENTS & INSTRUMENT TRAYS (Apr 12, 1983)
  • K822893 — G.E.V. DISPOSABLE SCALPELS (Oct 22, 1982)
  • K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS (Jan 26, 1981)
  • K791886 — I.V. CARE KIT (Oct 26, 1979)
  • K791885 — I.V. START SET (Oct 22, 1979)
  • K791887 — CENTRAL VENOUS CATHETER DRESSING TRAY (Oct 17, 1979)
  • K791888 — CATHETER CARE KIT REORDER 7940&7941 (Oct 17, 1979)
  • K791889 — SUTURE REMOVAL TRAY, REORDER 7950&7951 (Oct 17, 1979)

Other clearances for product code HAO

  • K220920 — Matreneu Percutaneous Balloon Compression Kit (Sep 7, 2022)
  • K940973 — MULLAN GANGLION MICROCOMPRESSION SET (Sep 29, 1995)
  • K951492 — RIB RESECTOR (May 18, 1995)
  • K943115 — AUTO SUTURE PITUITARY SPINAL RONGEUR (Jul 25, 1994)
  • K942970 — AUTO SUTURE SPINAL ELEVATOR (Jul 20, 1994)
  • K942969 — AUTO SUTURE SPINAL NERVE HOOK (Jul 20, 1994)
  • K942971 — AUTO SUTURE SPINAL DISSECTOR (Jul 20, 1994)
  • K942967 — AUTO SUTURE SPINAL CURETTE (Jul 20, 1994)
  • K942968 — AUTO SUTURE SPINAL OSTEOTOME (Jul 20, 1994)
  • K923723 — SILICONE BRAIN SPATULA SET (Aug 12, 1992)

FDA data resources

Source: FDA 510(k) database entry for K802726. Report a data issue: hello@regdatalab.com.