Question 1

Who is the manufacturer of POWER RESECTOSCOPE CUTTING LOOP?

Accepted Answer

Power Analytics Corp. filed the 510(k) submission for POWER RESECTOSCOPE CUTTING LOOP (K951897).

Question 2

What is the FDA product code for POWER RESECTOSCOPE CUTTING LOOP?

Accepted Answer

FAS. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

Question 3

When was POWER RESECTOSCOPE CUTTING LOOP cleared by the FDA?

Accepted Answer

Jul 18, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for POWER RESECTOSCOPE CUTTING LOOP?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like POWER RESECTOSCOPE CUTTING LOOP?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K951897
Device Name	POWER RESECTOSCOPE CUTTING LOOP
Applicant	Power Analytics Corp.
Product Code	FAS · Gastroenterology, Urology
Decision Date	Jul 18, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2

POWER RESECTOSCOPE CUTTING LOOP

Device Facts

Regulatory Classification

Identification