FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
K Number: K202944
·
Decision Mar 25, 2021
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
55
Review Days
176
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Basic Information
- Device Name
- NEBULAE SRS Laparoscopic Surgical Smoke Removal System
- K Number
- K202944
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Northgate Technologies, Inc.
- Date Received
- September 30, 2020
- Decision Date
- March 25, 2021
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| 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 |