510(k) clearances

SB Knife Jr2 (MD-47702 and MD-47702L)

Sb-Kawasumi Laboratories, Inc. · Gastroenterology, Urology

K241855Substantially EquivalentTraditionalKNS
Open FDA's page for this record
Third party flag
N
City
Kawasaki-Shi
Advisory committee description
Gastroenterology, Urology
Address 1
3-15-4 Tonomachi, Kawasaki-Ku
Statement or summary
Summary
Product code
KNS
Zip code
210-8602
Applicant
Sb-Kawasumi Laboratories, Inc.
Decision date
2025-03-26
Decision code
SESE
Country code
JP
Device name
SB Knife Jr2 (MD-47702 and MD-47702L)
Advisory committee
GU
Contact
Kenichi Inamura
K number
K241855
Date received
2024-06-27
Review advisory committee
GU
Postal code
210-8602
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Medical specialty description
Gastroenterology, Urology
Regulation number
876.4300
Device class
2
Registration number
3002806337, 3007593903, 9610612, 3030446844, 3018094310, 3013247477, 3010288205, 3035434483, 1223925, 1220592, 8010047, 1057358, 3007695959, 2183446, 3010707607, 9610773, 9612074, 1321175, 3013526170, 2133936, 3004837686, 3004111573, 3013557681, 3002808148, 3033589330, 3006621103, 2936485, 3002807310, 2246552, 3002894438, 9611503, 1320894, 3024021261, 1037905, 1056129, 9710641, 3011050570, 9680718, 9610617, 1000121056 +78 more
FEI number
3002806337, 3007593903, 3002808335, 3030446844, 3018094310, 3013247477, 3010288205, 3035434483, 3942, 3002806565, 1220592, 1000208608, 3007695959, 2183446, 3010707607, 2523865, 3001611427, 3002806816, 3002807091, 3002770040, 3013526170, 3004837686, 3004111573, 3013557681, 3002808148, 3033589330, 3002808268, 3006621103, 3002477156, 2936485, 3002807310, 2246552, 3002894438, 3002913962, 2648209, 1000138054, 3024021261, 1037905, 3011050570, 1000121056 +78 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.