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510(k) K831912

ROUND-BEEHIVE- DISSECTORS 3/8 by Ormed Mfg., Inc. — Product Code GDI

K831912 is an FDA 510(k) premarket notification submitted by Ormed Mfg., Inc. for the device "ROUND-BEEHIVE- DISSECTORS 3/8". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code GDI (Dissector, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Ormed Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
June 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dissector, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ormed Mfg., Inc.

  • K931555 — ARTROMOT K2 CPM (January 31, 1994)
  • K882527 — GAUZE SPONGE (July 18, 1988)
  • K882530 — TAPE STRUNG TONSIL SPONGE (July 18, 1988)
  • K882529 — BUTCHER STRUNG TONSIL SPONGE (July 18, 1988)
  • K882528 — CYLINDRICAL SPONGE (July 18, 1988)
  • K880909 — TRACHEOTOMY SPONGES (March 17, 1988)
  • K880852 — ROSEBUD DISSECTORS (March 17, 1988)
  • K880907 — TRIANGLE SPONGE (March 17, 1988)
  • K880853 — CHERRY SPONGE (March 17, 1988)
  • K880851 — FLAT STICK SPONGE (March 17, 1988)

Other clearances for product code GDI

  • K896383 — DISPOSABLE EXTERNAL CLAMPS (December 6, 1989)
  • K850288 — HEPATIC PARENCHYMAL SUCTION DISSECTOR (March 18, 1985)
  • K822569 — TYMPANOPLASTY & SKIN DISSECTORS (October 6, 1982)
  • K803292 — FIELD SUCTION DISSECTOR (January 29, 1981)
  • K791870 — DISPOSABLE SPECIALITY SPONGES (November 5, 1979)
  • K791703 — TEW BYPASS INSTRUMENTS & DISSECTING KIT (October 4, 1979)

FDA data resources