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FDA 510(k)

ROCKET CERVICAL SPATULA

K-Number: K884042 · 1988-10-07

ApplicantA & A Medical, Inc.
Decision Date1988-10-07
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ROCKET CERVICAL SPATULA is the device name listed in this FDA 510(k) record. The listed applicant is A & A Medical, Inc.. It received FDA 510(k) clearance on 1988-10-07 under 510(k) number K884042. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCKET CERVICAL SPATULA?

ROCKET CERVICAL SPATULA is a medical device that received FDA 510(k) clearance on 1988-10-07. The listed applicant is A & A Medical, Inc.. The 510(k) number is K884042.

When did ROCKET CERVICAL SPATULA receive FDA 510(k) clearance?

ROCKET CERVICAL SPATULA received FDA 510(k) clearance on 1988-10-07, under 510(k) number K884042.

Who is the listed applicant for ROCKET CERVICAL SPATULA?

The FDA 510(k) record lists A & A Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCKET CERVICAL SPATULA?

The FDA product code for ROCKET CERVICAL SPATULA is HHT.

Related Clinical Trials

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Other records listing A & A Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013491HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948K013437SF SH CATHETER, MODEL R65-945K003949TACKER, MODEL R65-933K011512MMODIFICATION TO LAMINARIAK010510BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1K010789CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1

View all 23 devices →

Related Devices (Code: HHT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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