NQGClass I

Stabilizer, Heart, Non-Compression, Reprocessed

21 CFR 870.4500 / Cardiovascular

NQG is the FDA product code for Stabilizer, Heart, Non-Compression, Reprocessed, a class I device type, regulated under 21 CFR 870.4500. FDA's definition for this code reads: "The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 2007-08-17, and no recalls.

Classification record

Product code: NQG
Device name: Stabilizer, Heart, Non-Compression, Reprocessed
FDA definition: The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation: 21 CFR 870.4500
Device class: Class I
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code NQG

By decision year

3 clearances under product code NQG with a decision year between 2007 and 2007, 2007 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code NQG by decision year
Year	Clearances
2007	3

Applicants with the most clearances

Product code NQG

Applicants holding the most 510(k) clearances under product code NQG
Applicant	Clearances
Stryker Sustainability Solutions	2
Sterilmed Inc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Sterigenics U.S., LLC

Recent clearances

Product code NQG

Recent recalls

Product code NQG

FDA records show no recalls under product code NQG.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)