NUCLEOTOME E KIT— 510(k) K931109

Name: FDA 510(k) clearance K931109
Creator: U.S. Food and Drug Administration
Published: 1994-03-29

Substantially Equivalent for Some Indications

Surgical Dynamics, Inc.

FDA 510(k) clearance K931109 for NUCLEOTOME E KIT, Substantially Equivalent for Some Indications on 1994-03-29. Applicant: Surgical Dynamics, Inc.. Device class: 2.

Clearance details

Applicant: Surgical Dynamics, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1993-03-03
Decision date: 1994-03-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

view all

K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

More clearances from Surgical Dynamics, Inc.

view all

K960046 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE1996-04-02
K942987 — NUCLEOTOME L KIT1995-10-30
K954193 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET1995-10-23
K950495 — SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-40001995-05-09
K921950 — SURGICAL DYNAMICS DISCOGRAPHY SYSTEM1993-06-07

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.