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510(k) K921950

SURGICAL DYNAMICS DISCOGRAPHY SYSTEM by Surgical Dynamics, Inc. — Product Code FMI

K921950 is an FDA 510(k) premarket notification submitted by Surgical Dynamics, Inc. for the device "SURGICAL DYNAMICS DISCOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 7, 1993. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Surgical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 7, 1993
Date Received
April 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Surgical Dynamics, Inc.

  • K960046 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE (April 2, 1996)
  • K942987 — NUCLEOTOME L KIT (October 30, 1995)
  • K954193 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET (October 23, 1995)
  • K950495 — SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 (May 9, 1995)
  • K931109 — NUCLEOTOME E KIT (March 29, 1994)
  • K923525 — NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR (February 9, 1993)
  • K914282 — NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER (December 19, 1991)
  • K913145 — NUCLEOTOME TISSUE ASPIRATOR/CUTTER (December 19, 1991)
  • K902778 — SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER (October 30, 1990)
  • K894336 — SURGICAL DYNAMICS DISCOGRAPHY SYSTEM (August 4, 1989)

Other clearances for product code FMI

  • K261266 — MOWANA™ Auto Duo (September 17, 2026)
  • K261719 — Promisemed X-Safety Pen Needle (August 25, 2026)
  • K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, (August 10, 2026)
  • K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, N (August 7, 2026)
  • K261829 — Profoject™ Dual-Safety Pen Needles (July 29, 2026)
  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)

FDA data resources