ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0— 510(k) K031974

Clearance details

Applicant

Asap Endoscopic Products GmbH

Product code

Code HIH

Device class

Class 2

Regulation

21 CFR 884.1690

Advisory panel

Obstetrics/Gynecology

Date received

2003-06-26

Decision date

2003-09-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Luebeck, DE

• K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)2026-09-08
• K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)2026-08-18
• K253020 — Strauss Surgical Resection Instruments2026-06-04
• K254050 — Manual Tissue Removal Device2026-05-15
• K254251 — InnovexView (GC146-17, GC150-20, GC155-23)2026-02-26

• 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
• K031972 — ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,2003-09-15
• K031141 — ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE2003-06-30

Death

18

Injury

973

Malfunction

5,071

Other

1

Total

6,063

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 →