HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT— 510(k) K844551

Name: FDA 510(k) clearance K844551
Creator: U.S. Food and Drug Administration
Published: 1985-01-03

Substantially Equivalent

Gobbs Medical, Inc.

FDA 510(k) clearance K844551 for HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT, Substantially Equivalent on 1985-01-03. Applicant: Gobbs Medical, Inc.. Device class: 1.

Clearance details

Applicant: Gobbs Medical, Inc.
Product code: Code FCL
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1984-11-21
Decision date: 1985-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palmer, MA, US

Download summary PDF View on FDA.gov ↗

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K973611 — SPECTRASCIENCE REUSABLE BIOPSY FORCEPS1997-12-02
K971315 — AUXILIARY INSTRUMENTS FOR URS1997-09-15
K964120 — INJECTO FLUSH1996-12-30
K963517 — SPECTRA SCIENCE BIOPSY FORCEPS1996-12-02

Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.