510(k) clearances

Monik™ - Disposable Endoscopic Trocar

M/s. Meril Endo Surgery Private Limited. · Gastroenterology, Urology

K233386Substantially EquivalentTraditionalGCJ
Open FDA's page for this record
Third party flag
N
City
Vapi
Advisory committee description
Gastroenterology, Urology
Address 1
Third Floor, E1-E3, Meril Park, Survey # 135/2/B & 174/2,
Address 2
Muktanand Marg, Chala
Statement or summary
Summary
Product code
GCJ
Zip code
396191
Applicant
M/s. Meril Endo Surgery Private Limited.
Decision date
2024-05-24
Decision code
SESE
Country code
IN
Device name
Monik™ - Disposable Endoscopic Trocar
Advisory committee
GU
Contact
Umesh Sharma
K number
K233386
Date received
2023-10-02
Review advisory committee
SU
Postal code
396191
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Laparoscope, General & Plastic Surgery
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1500
Device class
2
Registration number
3015497424, 3013247477, 3008044552, 1720747, 3045813414, 8010273, 2518897, 1057358, 3002806603, 2029015, 3011373951, 9681129, 3016248634, 3014991167, 3008864603, 3003139373, 3005110411, 8043746, 3004111573, 3002808148, 3043226252, 3010437008, 2183425, 3007345416, 3010043098, 3022626486, 3008911114, 3010400367, 3014635169, 9611503, 3021336182, 2434839, 3014273609, 3038188839, 2523676, 3011230048, 2530138, 3010601984, 3032391, 3010684280 +534 more
FEI number
3015497424, 3013247477, 3008044552, 1720747, 1000136191, 3045813414, 3001319476, 3002806603, 3002808127, 3011373951, 1000208624, 3006469671, 3016248634, 3014991167, 2523865, 3008864603, 3003139373, 3932, 3005110411, 3002806575, 3000226659, 3004111573, 3002808148, 3043226252, 3010437008, 2183425, 3007345416, 3010043098, 1000120548, 3022626486, 3008911114, 3010400367, 3014635169, 3008782585, 3021336182, 2434839, 3014273609, 3038188839, 2523676, 3011230048 +534 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.