FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOLITH TOUCH; URO TOUCH
K Number: K130368
·
Decision Nov 15, 2013
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
55
Review Days
274
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AUTOLITH TOUCH; URO TOUCH
- K Number
- K130368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Northgate Technologies, Inc.
- Date Received
- February 14, 2013
- Decision Date
- November 15, 2013
- Product Code
- FFK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFK), ordered by most recent decision date.
Electrohydraulic Lithotriptor (TCS-B3-II)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EL27-Compact; Sterile EHL-Probes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
URO-TOUCH 9 French Probe
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Swiss LithoClast Trilogy
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UreTron PF Series Probe
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Northgate Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202813 | URO-TOUCH 9 French Probe | Jun 14, 2021 | Substantially Equivalent |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Mar 25, 2021 | Substantially Equivalent |
| K120151 | NEBULAE I | Aug 17, 2012 | Substantially Equivalent |
| K041560 | FLO-ASSISTANT | Sep 28, 2004 | Substantially Equivalent |
| K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | Jul 29, 2004 | Substantially Equivalent |
| K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | Jan 24, 2003 | Substantially Equivalent |
| K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | Oct 23, 2001 | Substantially Equivalent |
| K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 | Aug 10, 2001 | Substantially Equivalent |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | Aug 18, 2000 | Substantially Equivalent |
| K993778 | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 | Jan 6, 2000 | Substantially Equivalent |