Home / 510(k) Clearances / K841981

510(k) K841981

4MM & 5MM FILE by Stainless Mfg., Inc. — Product Code HTP

K841981 is an FDA 510(k) premarket notification submitted by Stainless Mfg., Inc. for the device "4MM & 5MM FILE". The FDA issued a decision of Substantially Equivalent on June 19, 1984. The device falls under product code HTP (File), a Class I device regulated under 21 CFR 888.4540. Stainless Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
May 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Stainless Mfg., Inc.

  • K841980 — SIDE CUTTING SERRATED BLADE (August 15, 1984)
  • K841982 — MENISCOTOME 4MM & 5MM (June 19, 1984)
  • K841977 — 5MM DOUGLE EDGE RING CURETTE (June 19, 1984)
  • K841976 — HOOK KNIFE 4MM & 5MM (June 19, 1984)
  • K841979 — 4MM CUP CURRETTE (June 19, 1984)
  • K841975 — ROSETTE KNIFE 4MM (June 19, 1984)
  • K841972 — BANANA KNIFE - K841969-LABELING (June 19, 1984)
  • K841974 — RETROGRADE KNIFE 4MM & 5MM (June 19, 1984)
  • K841978 — LATERAL RELEASE KNIFE 5MM & 7MM (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)

Other clearances for product code HTP

  • K931733 — INTERMEDICS ORTHOPEDICS REAMERS (January 26, 1994)
  • K870842 — SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (May 27, 1987)
  • K862659 — CONCEPT ARTHROSCOPY RASP (September 2, 1986)
  • K840492 — SUN-LITE BLUE SLIT (May 9, 1984)

FDA data resources