Hand Extractor Hector
by Karl Storz Endoscopy 510(k)
Active
510(k) K953109
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953109 | Date25 Aug 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1690
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
A hand extractor device used in obstetrics and gynecology procedures. It is classified as a hysteroscope accessory under FDA device class 2.
The device received FDA 510(k) clearance K953109 on August 25, 1995, and is substantially equivalent to a legally marketed device. It is manufactured by Karl Storz Endoscopy and supplied as a reusable instrument requiring proper cleaning and maintenance per manufacturer instructions.
Other devices from Karl Storz Endoscopy
Questions
AI-generated answers, 25 Sep 2026
What is the HAND EXTRACTOR HECTOR used for?
The HAND EXTRACTOR HECTOR is a hand extractor device used in obstetrics and gynecology procedures, specifically classified as a hysteroscope accessory for use during hysteroscopic interventions.
Is the HAND EXTRACTOR HECTOR reusable or single-use?
The HAND EXTRACTOR HECTOR is supplied as a reusable instrument, requiring proper cleaning and maintenance per the manufacturer's instructions to ensure safe and effective repeated use.
Who manufactures the HAND EXTRACTOR HECTOR and where is it authorized?
The HAND EXTRACTOR HECTOR is manufactured by Karl Storz Endoscopy and received FDA 510(k) clearance K953109 on August 25, 1995, indicating it is substantially equivalent to a legally marketed device.