FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASY LOOP, MODEL EZL-01
K Number: K040110
·
Decision Mar 24, 2004
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
1
Applicant Total
4
Review Days
64
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
- EASY LOOP, MODEL EZL-01
- K Number
- K040110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4270
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tools For Surgery, LLC
- Date Received
- January 20, 2004
- Decision Date
- March 24, 2004
- Product Code
- EZP
- 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 |
|---|---|---|---|
| EZP | Rod, Colostomy | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZP), ordered by most recent decision date.
View allOther Clearances by Tools For Surgery, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) | Jan 10, 2025 | Substantially Equivalent |
| K220218 | Siren SGT | May 18, 2022 | Substantially Equivalent |
| K040109 | HEMORRHAGE OCCLUDER PIN | Mar 25, 2004 | Substantially Equivalent |