Question 1

Who is the manufacturer of GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L?

Accepted Answer

Medi-Source, Inc. filed the 510(k) submission for GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L (K903402).

Question 2

What is the FDA product code for GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L?

Accepted Answer

GXY. It is classified under 21 CFR 882.1320 as a Class 2 device in the Neurology panel.

Question 3

When was GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L cleared by the FDA?

Accepted Answer

Aug 22, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L?

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	K903402
Device Name	GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L
Applicant	Medi-Source, Inc.
Product Code	GXY · Neurology
Decision Date	Aug 22, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1320
Device Class	Class 2

GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L

Device Facts

Regulatory Classification

Identification