MANUAL RONGEUR— 510(k) K874954

Name: FDA 510(k) clearance K874954
Creator: U.S. Food and Drug Administration
Published: 1987-12-30

Substantially Equivalent

Solway, Inc.

FDA 510(k) clearance K874954 for MANUAL RONGEUR, Substantially Equivalent on 1987-12-30. Applicant: Solway, Inc.. Device class: 1.

Clearance details

Applicant: Solway, Inc.
Product code: Code HTX
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1987-12-02
Decision date: 1987-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTX

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K841620 — FRONT RADIUS CUTTER1984-09-20
K841621 — BACK RADIUS CUTTER1984-09-20
K780397 — ORTHOPEDIC FORCEPS1978-03-22
K760325 — SURGICAL INSTRUMENTS, ORTHOPEDIC1976-08-03

More clearances from Solway, Inc.

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K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTS1988-02-05
K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS1988-02-02
K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERY1988-01-28
K874964 — DENTAL HAND INSTRUMENTS1988-01-27
K875043 — RONGEUR (NEUROSURGICAL INSTRUMENTS)1988-01-22

Adverse events under product code HTX

product code HTX

Other: 1
Total: 1

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.