Daniell DBL Puncture Laser Laparoscopy
510(k) K842498
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842498 | Date25 Sep 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HET
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1720
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Daniell DBL Puncture Laser Laparoscopy is a laparoscope, gynecologic (and accessories) device used in obstetrics and gynecology. It is a laser-based laparoscopic system designed for minimally invasive surgical procedures.
This device received FDA 510(k) clearance (K842498) on September 25, 1984, and is classified as a Class II medical device. It is manufactured by Laser Spectrum, Inc. and is intended for use in clinical settings under the obstetrics/gynecology specialty.
Other devices from Laser Spectrum, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the Daniell DBL Puncture Laser Laparoscopy used for?
It is a laser-based laparoscopic system designed for minimally invasive surgical procedures in obstetrics and gynecology, intended for use in clinical settings under that specialty.
Who manufactures the Daniell DBL Puncture Laser Laparoscopy and what is its FDA clearance status?
It is manufactured by Laser Spectrum, Inc. and received FDA 510(k) clearance (K842498) on September 25, 1984, as a substantially equivalent Class II device.
What regulatory classification and product code apply to the Daniell DBL Puncture Laser Laparoscopy?
It is classified as a Class II medical device with product code HET and regulation number 884.1720, falling under the Obstetrics/Gynecology medical specialty.