Trapsystem Set
by H.S. Hospital Service S.R.L. 510(k)
Active
510(k) K013692
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013692 | Date5 Feb 2002 | 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- Withdrawn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
- KNW
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The TRAPSYSTEM SET is a device classified under the product code KNW, which corresponds to a gastroenterology and urology device as indicated by the advisory committee review. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.
The device was manufactured by H.S. Hospital Service S.R.L. and received FDA 510(k) clearance under K013692 on February 5, 2002, following submission on November 7, 2001. It is authorized for distribution in the United States, with the applicant and manufacturer located in Boca Raton, Florida.
Other devices from H.S. Hospital Service S.R.L.
Questions
AI-generated answers, 19 Sep 2026
What is the TRAPSYSTEM SET intended for based on its classification?
The TRAPSYSTEM SET is classified under product code KNW, which corresponds to a gastroenterology and urology device as indicated by the advisory committee review, meaning it is intended for use in procedures related to those specialties.
How was the TRAPSYSTEM SET cleared for marketing in the United States?
The TRAPSYSTEM SET received FDA 510(k) clearance through a traditional submission process, determined to be substantially equivalent to a predicate device, as stated in its decision description and clearance type.
When did the TRAPSYSTEM SET receive its FDA 510(k) clearance?
The TRAPSYSTEM SET received FDA 510(k) clearance on February 5, 2002, following submission on November 7, 2001, as documented in the decision date and date received fields.
Who is the manufacturer and applicant of the TRAPSYSTEM SET?
The manufacturer and applicant of the TRAPSYSTEM SET is H.S. Hospital Service S.R.L., located in Boca Raton, Florida, as specified in the applicant and manufacturer fields.
What regulatory pathway was used for the TRAPSYSTEM SET’s clearance?
The TRAPSYSTEM SET was cleared via a traditional 510(k) pathway, as indicated by the clearance_type field, which confirms it followed the standard premarket notification process for demonstrating substantial equivalence.