IWD-젤™
K-번호: K254191 · 2026-04-07
광고
기기 요약
IWD-Gel™ is the device name listed in this FDA 510(k) record. The listed applicant is InnovaCorium, Inc.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K254191. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
자주 묻는 질문
What is the IWD-Gel™?
IWD-Gel™ is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is InnovaCorium, Inc.. The 510(k) number is K254191.
When did IWD-Gel™ receive FDA 510(k) clearance?
IWD-Gel™ received FDA 510(k) clearance on 2026-04-07, under 510(k) number K254191.
Who is the listed applicant for IWD-Gel™?
The FDA 510(k) record lists InnovaCorium, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IWD-Gel™?
The FDA product code for IWD-Gel™ is FRO. This falls under the Anesthesiology category.
관련 기기 (코드: FRO)
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
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공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.
광고