ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,— 510(k) K031972

Clearance details

Applicant

Asap Endoscopic Products GmbH

Product code

Code HRX

Device class

Class 2

Regulation

21 CFR 888.1100

Advisory panel

Orthopedic

Date received

2003-06-26

Decision date

2003-09-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Luebeck, DE

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• K121261 — ASAP MUITISCOPE2013-01-08
• K032822 — ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-02004-01-08
• K031974 — ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-02003-09-29
• K031141 — ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE2003-06-30

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 →