Electronic Insufflator Model 2054.61
by Richard Wolf Medical Instruments Corp. 510(k)
Active
510(k) K921756
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921756 | Date28 Mar 1994 | 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- Withdrawn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
- HIF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1730
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Electronic Insufflator Model 2054.61 is a laparoscopic insufflator. It is designed to facilitate laparoscopic procedures by providing controlled gas insufflation.
This device is manufactured by Richard Wolf Medical Instruments Corp. and has received FDA 510(k) clearance. It is categorized under the medical specialty of Obstetrics and Gynecology.
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Questions
AI-generated answers, 23 Sep 2026
What is the primary function of the Electronic Insufflator Model 2054.61?
This device is a laparoscopic insufflator designed to facilitate surgical procedures by providing controlled gas insufflation, which creates the necessary space for laparoscopic access.
Which medical specialty is this device intended for?
The Electronic Insufflator Model 2054.61 is categorized under the medical specialty of Obstetrics and Gynecology.
What is the regulatory status of this device?
The device has received FDA 510(k) clearance, which indicates that it has been determined to be substantially equivalent to a legally marketed predicate device.